Evaluate the change in glycemic control as measured by HbA1c from Baseline to Week 12

Original Primary Outcome Measures ICMJE (submitted: August 1, 2006)

To test the hypothesis that glycemic control achieved with exenatide administered subcutaneously before lunch and dinner is noninferior to that obtained with the administration before breakfast and dinner in patients with type 2 diabetes.

Changes in glucose measured at different times throughout the day derived from 7-point SMBG profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)

Original Secondary Outcome Measures ICMJE (submitted: August 1, 2006)

To compare exenatide administered either before breakfast and dinner or before lunch and dinner with respect to various pharmacodynamic measurements, body weight, and safety and tolerability.

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes

Official Title ICMJE

Safety and Efficacy of Exenatide Taken Before Lunch and Before Dinner Compared With Before Breakfast and Before Dinner in Patients With Type 2 Diabetes Using Oral Antidiabetic Therapy

Brief Summary

This trial is designed to compare the effects of twice-daily (before lunch and before dinner) exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before dinner) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2 diabetes.

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

377

Completion Date

July 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Diagnosed with type 2 diabetes.

Have been treated with one of the following treatment regimens for at least three months prior to screening: *metformin alone; *sulfonylurea (SU) alone; *thiazolidinedione (TZD) alone; *a combination of metformin and SU; *a combination of metformin and TZD.

HbA1c between 7.1% and 10.0%, inclusive.

Body Mass Index (BMI) > 25 kg/m^2 and < 45 kg/m^2

Exclusion Criteria:

Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental drug, medical, or surgical treatment was given) within 30 days prior to screening.

Have characteristics contraindicating metformin, SU, or TZD use.

Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening.

Have used any prescription drug to promote weight loss within 3 months prior to screening.

Are currently treated (for greater than 2 consecutive weeks) with any of the following excluded medications: *insulin within 3 months prior to screening; *alpha-glucosidase inhibitors within 3 months prior to screening; *meglitinides within 3 months prior to screening; *drugs that directly affect gastrointestinal motility

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects